Compliance Approvals

FDA – 2014

German Authorities - 2014

ANVISA - 2009

EMEA - 2007

Facility Legacy

CordenPharma Plankstadt GmbH is an expert manufacturer of solid dosage forms with special expertise in formulation of highly potent products, offering a full range of services from pharmaceutical development for phase I-III, and commercial scale manufacturing, to packaging and pharma-logistics (CEE-hub) for a global market.

As a former operations site of AstraZeneca, CordenPharma Plankstadt has extensive expertise and capabilities in two facilities for the formulation of solid dosage products, for both non-potent and highly potent drug products, including cytotoxics and hormones with a clearly defined OEL/PDE value.
Since its transition to CordenPharma in 2008, CordenPharma Plankstadt has also increased its development capabilities for highly potent drug products, growing its reputation as an expert in the QbD based development of oral solid dosage forms.

CordenPharma Plankstadt has two plants available for the manufacturing of highly potent drug products. Highly potent drug products with a clearly defined OEL/PDE value can either be manufactured in a fully contained facility employing primary containment at a batch size of 100 – 150 kg or in a segregated area within the standard facility. In this smaller facility hormones can be manufactured at a batch size of 60-120 kg using secondary containment and PPE.

History

1970 Rhein-Pharma (Imperial Chemical Industries / Rhein-Chemie) sets up a new production site at Plankstadt

Start-up of packing facility

1978 Production is expanded by a new active substance purification facility

Start-up of formulation facility

1983 Expansion of the laboratory capacities

2002 Start-up of the high-containment tablet production facility

2007/2008 former AstraZeneca Plankstadt plant acquired by ICIG to become CordenPharma Plankstadt Gmbh